A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase IIa/IIb Study to Evaluate the Safety, Tolerability, and Efficacy of NP-101 in Treating High-Risk Participants Who Have Tested Positive for Novel Coronavirus 2019

Kaseb et al., NCT05785390, BOSS-002, NCT05785390, Aug 2026
Progression 60% improvement lower risk ← → higher risk Long COVID 42% Recovery -10% Recovery time -25% Recovery time, compl.. 12% Recovery time, com.. b 19% Nigella Sativa  BOSS-002  EARLY TREATMENT RCT Is early treatment with nigella sativa beneficial for COVID-19? Double-blind RCT 110 patients in the USA Lower progression with nigella sativa (p=0.0065) c19early.org Kaseb et al., NCT05785390, August 2026 0 0.5 1 1.5 2+ RR
13th treatment shown to reduce risk in January 2021, now with p = 0.00003 from 15 studies.
Lower risk for ventilation, hospitalization, progression, recovery, cases, and viral clearance.
No treatment is 100% effective. Protocols combine treatments.
6,600+ studies for 220+ treatments. c19early.org
Meta-analysis
RCT 110 high-risk outpatients showing significantly lower COVID-19 progression with NP-101 (thymoquinone from Nigella sativa with fatty acids, including palmitic, oleic, and linoleic acids), but no significant difference for the primary day-5 sustained-recovery endpoint. Long COVID risk was lower, without reaching statistical significance (RR=0.58, p=0.07). There were no deaths, serious adverse events, or hospitalizations in either arm, and there were fewer adverse events with treatment (19/50 vs. 32/60). Currently results are only available in the registry.
Standard of Care (SOC) for COVID-19 in the study country, the USA, is very poor with very low average efficacy for approved treatments1. Only expensive, high-profit treatments were approved for early treatment. Low-cost treatments were excluded, reducing the probability of early treatment due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.
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risk of progression, 60.0% lower, RR 0.40, p = 0.006, treatment 8 of 50 (16.0%), control 24 of 60 (40.0%), NNT 4.2, symptom progression, defined as worsening from none/mild to moderate/severe for >=2 days, or hospitalization/death due to COVID-19 worsening, day 28.
risk of long COVID, 41.8% lower, RR 0.58, p = 0.07, treatment 12 of 49 (24.5%), control 24 of 57 (42.1%), NNT 5.7, long COVID symptoms reported on any assessment at days 30, 37, or 45.
risk of no recovery, 10.0% higher, RR 1.10, p = 0.70, treatment 22 of 50 (44.0%), control 24 of 60 (40.0%), failure to achieve sustained clinical recovery by day 5, day 5.
recovery time, 25.0% higher, relative time 1.25, p = 0.70, treatment 5.0 [4.0-5.0] n=50, control 4.0 [4.0-5.0] n=60, median days to sustained clinical recovery.
recovery time, 12.2% lower, relative time 0.88, p = 0.63, treatment 18.0 [7.0-23.0] n=50, control 20.5 [12.0-25.0] n=60, median days to complete clinical recovery.
recovery time, 19.1% lower, relative time 0.81, p = 0.35, treatment 19.0 [11.0-27.0] n=50, control 23.5 [16.0-27.0] n=60, median days to complete clinical resolution.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Kaseb et al., 13 Aug 2026, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, trial NCT05785390 (history) (BOSS-002). Contact: akaseb@novatekpharmaceuticals.com.
$0 $500 $1,000+ Efficacy vs. cost for COVID-19 treatment protocols c19early.org August 2026 USA Angola Colombia Kenya Mozambique Myanmar South Africa Peru Philippines Vietnam Japan Nepal China Uzbekistan Iran Bangladesh Ethiopia Ghana Germany Mexico South Korea Saudi Arabia Algeria Morocco Yemen Poland India Venezuela DR Congo Madagascar Thailand Uganda Egypt Nigeria Taiwan Zambia Bolivia Fiji Bosnia-Herzegovina Jordan Georgia Switzerland Ukraine Côte d'Ivoire Bulgaria Greece Slovakia Singapore Iceland New Zealand Trinidad and Tobago Mongolia Czechia Israel Belarus North Macedonia Hong Kong Qatar Panama Serbia CAR Syria USA favored high-profit treatments.The average efficacy of treatments was very low.High-cost protocols reduce early treatment, andforgo complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
$0 $500 $1,000+ Efficacy vs. cost for COVID-19treatment protocols worldwide c19early.org August 2026 USA Angola Colombia Kenya Mozambique Myanmar South Africa Peru Philippines Vietnam Japan Nepal China Uzbekistan Iran Bangladesh Ethiopia Ghana Germany Mexico South Korea Saudi Arabia Algeria Morocco Yemen Poland India Venezuela DR Congo Madagascar Thailand Uganda Egypt Nigeria Taiwan Zambia Bolivia Fiji Jordan Georgia Switzerland Ukraine Côte d'Ivoire Eritrea Bulgaria Greece Slovakia Singapore Iceland New Zealand Mongolia Czechia Israel Belarus North Macedonia Hong Kong Qatar Panama Serbia CAR USA favored high-profit treatments.The average efficacy was very low.High-cost protocols reduce early treatment,and forgo complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
Please send us corrections, updates, or comments. c19early involves the extraction of 200,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. IMA and WCH provide treatment protocols.
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